Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD (TERPSIS)

A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in Major Depressive Disorder (TERPSIS STUDY)

To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).

Study Overview

• Status: Completed
• Conditions: Anhedonia; Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: NBI-1065846

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00926
    • Neurocrine Clinical Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Neurocrine Clinical Site
  • California
    • Garden Grove, California, United States, 92845
      • Neurocrine Clinical Site
    • Lemon Grove, California, United States, 91945
      • Neurocrine Clinical Site
    • Orange, California, United States, 92868
      • Neurocrine Clinical Site
    • Riverside, California, United States, 92506
      • Neurocrine Clinical Site
    • San Diego, California, United States, 92103
      • Neurocrine Clinical Site
    • San Francisco, California, United States, 94107
      • Neurocrine Clinical Site
  • Florida
    • Orlando, Florida, United States, 32803
      • Neurocrine Clinical Site
    • Pensacola, Florida, United States, 32502
      • Neurocrine Clinical Site
    • Winter Park, Florida, United States, 32792
      • Neurocrine Clinical Site
  • Georgia
    • Atlanta, Georgia, United States, 30338
      • Neurocrine Clinical Site
  • Illinois
    • Chicago, Illinois, United States, 60641
      • Neurocrine Clinical Site
    • Skokie, Illinois, United States, 60076
      • Neurocrine Clinical Site
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • Neurocrine Clinical Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Neurocrine Clinical Site
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Neurocrine Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Neurocrine Clinical Site
  • Texas
    • Dallas, Texas, United States, 75235
      • Neurocrine Clinical Site
    • Friendswood, Texas, United States, 77546
      • Neurocrine Clinical Site
    • Houston, Texas, United States, 77030
      • Neurocrine Clinical Site
  • Utah
    • Murray, Utah, United States, 84107
      • Neurocrine Clinical Site
  • Washington
    • Everett, Washington, United States, 98201
      • Neurocrine Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

Participants must meet all of the following key inclusion criteria:

1. Completed written informed consent.
2. Aged 18 to 65 years, inclusive, at the time of informed consent.
3. Primary diagnosis of MDD.

4. Participants must meet one of the following criteria:

   • must have been taking ≥1 antidepressant medication(s) for ≥8 weeks prior to screening.
   • must have received ≥1 antidepressant medication(s) for ≥8 weeks in the current or most recent episode of depression.
5. Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following key criteria:

1. Any psychiatric disorder disallowed per protocol and electroconvulsive therapy (ECT) within 6 months prior to screening. Comorbid anxiety disorders are not exclusionary.
2. Have a significant risk of suicidal or violent behavior.
3. A history of seizure disorder, stroke, Alzheimer disease, Parkinson disease, multiple sclerosis, head injury associated with loss of consciousness for more than 15 minutes, or other neurodegenerative disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participant follows Placebo schedule (57 days)	Drug: Placebo; Tablets for oral administration
Experimental: Antidepressant; Participant follows NBI-1065846 schedule (57 days)	Drug: NBI-1065846; Tablets for oral administration; Other Names: TAK-041

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57	The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68.	Baseline, Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression	The MADRS is a validated rating scale designed to measure changes in the severity of depressive symptoms. The MADRS consists of 10 items scored on a 7-point scale (0 to 6). Higher MADRS scores indicate more severe depression. The MADRS total score was calculated as the sum of the 10 individual item scores which ranges from 0 to 60.	Baseline, Day 57
CGI-S Scores	The CGI-S scale, which is based on a 7-point scale (range: 1=normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = extremely ill), was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.	Baseline and Day 57

Collaborators and Investigators

• Sponsor: Neurocrine Biosciences
• Investigators: Study Director: Clinical Development Lead, Neurocrine Biosciences

Publications and helpful links

Helpful Links

• Study Website - Terpsis Study

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Depression; MDD; Major Depressive Disorder; Anhedonia; Antidepressant; Neurocrine; NBI-1065846; TERPSIS; TAK-041
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Depression; Depressive Disorder; Anhedonia; Depressive Disorder, Major
• Other Study ID Numbers: NBI-1065846-MDD2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No